510(k) K981733

DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111 by Medtronic Functional Diagnostics A/S — Product Code FFX

K981733 is an FDA 510(k) premarket notification submitted by Medtronic Functional Diagnostics A/S for the device "DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111". The FDA issued a decision of Substantially Equivalent on February 4, 1999. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medtronic Functional Diagnostics A/S has at least 10 other 510(k) clearances on record.